Associate Director, Global Clinical Data Standards Vocabulary Specialist
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Job Description
Associate Director specializing in Global Clinical Data Standards at a clinical research company. Mentoring staff and collaborating on data governance and standardization initiatives.
Responsibilities:
- work independently or collaboratively as a member of a team or successful leader
- interact with staff across multiple company sites
- mentor, guide and provide direction to junior staff
- lead or participate in internal clinical data standards forums
- support standards development teams and data governance reviews
- engage in strategic and process improvement/design projects
- contribute to industry forums and standards development teams
- maintain knowledge of new technologies, clinical study data standards and regulatory requirements
Requirements:
- 8 years’ work experience in pre-clinical/clinical research
- minimum 2 years’ experience in data standards
- strong emphasis on managing and applying CDISC Controlled Terminology
- knowledge of clinical research-controlled terminology (i.e., MedDRA, WHODD, SNOMED)
- understanding of various external data types (i.e., genetics, immunogenicity, PK/PD)
- understanding of collection and terminology associated with questionnaires
- understanding of lab values and the importance and maintenance of unit of measure conversions
- knowledge of versioning and maintenance of controlled terminology
- excellent communication/presentation skills
- must have an innovative spirit and outstanding stakeholder management skills
- ability to manage multiple projects
Benefits:
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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